7.01MB - BL Lifesciences

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B L Lifesciences
BL Lifesciences
Medical Device Manufacturing Company
Established in 1984
Part of the 65 years old BL Group of companies..
Started as family owned business run by the Aggarwal
family..
Group activities include one of the largest & oldest
Pharmacy in Delhi, Exports of Apparel… besides
Manufacturing & Marketing several Bio Medical Devices in
India and internationally
BL Lifesciences
specializes in the fields of
Cardiovascular Surgery
Cardiac Anesthesia
Critical Care
Interventional Cardiology
BL Lifesciences
Manufacturing
Distribution
for several indigenous, own
branded products
representing several world
leaders in the fields of
Medical Technology..
Distribution Products
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Integra Luxtec, USA (Head light source, Camera system)
Integra Omni-Tract, USA (Retractors)
Scanlan, USA (Surgical Instruments)
3M - Arizant, USA (Patient warmers, Fluid/Blood warmer)
Chase Medical, USA (Cardiovascular shunts)
Helena Lab., USA (ACT machine)
Minntech, USA (Hemoconcentrators)
Medos, Germany (Oxygenators and others)
Vitalitec Corpn., France (Hemostasis Clips)
On-X, USA (Heart valves)
Cryolife, USA (Surgical glue)
Thoratec, USA (Left Ventricular Assist Device)
Novalung, Germany (Membrane ventilator)
Rontis, Swiss (Coronary stents)
Oscar, USA (Angiography catheters and other)
Minvasys (Bifucation stents)
Nonin, USA (Cerebral Oxymetry)
Purple Surgical (Laproscopy Instruments)
BL Manufacturing
Operations
Employing over a total of 400 people in the medical division..
With strong sales force of 70 personnel..
Spread over 11 branches and additional 10 regional / representative
offices across India..
•Corporate Office :
A 245, Okhla Industrial Area, Phase 1, NEW DELHI, 110020, India
•11 Branch offices INDIA :
New Delhi, Chennai, Bangalore, Hyderabad, Mumbai, Calcutta, Lucknow,
Ahmedabad, Chandigarh, Jaipur, Pune
•10 Regional Representative Offices INDIA :
•2 Manufacturing Facilities INDIA :
Greater Noida (Facility 1 & Facility 2 –under construction/renovation )
•3 Rep Offices OVERSEAS :
Singapore, Dubai UAE, Italy (EU Rep)
BL’s NETWORK All India Presence
BL Manufacturing facility at Greater Noida
Manufacturing facility
• Located in Greater Noida , India . About 32 kms outside of the
Delhi .
• State of Art Building designed in Compliance to all Statutory /
Regulatory requirements , our product requirements & future
growth in mind
• Total built up area
• Ware House
: 68,000 sq. ft.
: 25,000 sq. ft.
Manufacturing facility
• Current Staff Strength of over 200 operators and 50+ support
functional staff
• Seasoned design team , skilled production personnel and competent
Quality Control Team .
• Procurement & Supply Chain management team is experienced &
well versed with the dynamics of Business .
Manufacturing facility
• Class 10,000 Clean room for Assembly of products .
Clean Room ISO class 7 : 4,200 sq. ft.
• Additional space available to add another Clean room of 4000 sq ft.
Space available to add another ISO class 7 clean room of 4,000 sq. fS
• In house Molding & Tray forming
Molding
: 3,000 sq. ft.
• In house EO Sterilization Facility –750 cu ft.
• Fully Integrated Microbiological Lab.
Certifications & Compliances
• Compliance to Indian FDA
• Factory and Premises : The Drugs & Cosmetics Act 1940 &
Schedule M-III
• ISO 9001 : 2008 /13485:2003
• CE Mark
Certification ISO
Certification CE
Certification & Compliances
•Compliance to all Statutory & Regulatory Requirements
•Cleanroom and associated environments : ISO 14644-1:2009
•Biological Evaluation of Medical Devices : ISO 10993:2009
•Symbols to be used in Medical device Labels : ISO 15223-1:2007
•Application of Risk Management : EN 14971:2009
•Sterilization of health Care products : ISO 11135-1:2007
Manufacturing Activities at BL
Controlled entry into
the production area
ASSEMBLY AREA
Class 10,000
ASSEMBLY LINES
INHOUSE EO STERILIZATION
Two Sterilizers 540 & 200 Cu ft
Total Sterilization volume per day is 750 packs
Quarantine &
Storage Area
BL’ s STRENGTH
Expansion Plans of BL
In Addition to the Present Assembly Area; space available
to add another Clean room of 4000 sq ft
Adequate Storage Capacity Available too
BL
for
Tubing sets
TUBINGS
CLASS VI
PLAIN /REGULAR
DEHP FREE OPTIONS
COLORED
STERILIZATION
INDICATORS
ASSEMBLY LINES
PERFUSION PACKS –
TRAY FILLING
ASSEMBLED PACK
With EO INDICATOR
Visual Inspection of
Sealing
High Quality Products
at
Competitive Cost
Product is CE certified
BL’ s STRENGTH
•BL has been a leading Perfusion pack Manufacturer in INDIA since
Year 2000 . This is in addition to other product ranges of BL .
•BL’s current Annual Production capacity for Perfusion Pack is in
excess of 70,000 packs with a Single Shift Operation . We have the
potential to run multiple shifts to increase the Production Capacity .
BL’ s STRENGTH
High Level of Customization requires us to stay
in regular touch with each and every customer of
regular basis
BL’ s STRENGTH
•The Designs are created to suit all Users with Options of
components for all Adult /Pediatric /Neonatal/Infant applications
•Custom drawings can be made as early as 48 hours
•Sterile Samples are available at a short notice for Clinical
Evaluations
BL’ s STRENGTH
•Products are available in short lead times as the Sterilization
Process is In - house
•Customized Labeling available along with GS1
Barcoding
So how does BL’s strength lend you Competitive advantage ?
Fast Track Processing
Quick processing of drawings & price offer
Fast sampling
Customized label options
Flexibility on minimum order quantity
CUSTOMIZATION
The design can be customized with a interactive
approach between BL & buyer to minimize the cost
impact .
Shelf life
3 years, validated
Tubing
•Class VI Implant Tested
•Biocompatibility as per ISO 10993
•Options of Colored Tubing
•Options for DEHP Free Tubing
Labels
•GS1/GTIN barcodes
•Custom Labels available
In House Sterilization
•Sterile samples available in less time
•Production can be Fast Tracked
Sterilization indicators
•EO Tape Inside the product
•EO Indicator on the Product Header Bag
Tray Packaging
All the tubing sets are packed with the TRAY to
avoid Product Damage
Dedicated team
Years of Manufacturing Experience
Trained & experienced Operators/Supervisors
Trained & experienced Quality Team
Thank you
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